FDA CBER Expedited IND Pilot Applications Open in September Under Operation TrialBlazer; Comment Deadline September 22, 2026
The FDA Center for Biologics Evaluation and Research (CBER) opened applications in September 2026 for the Expedited IND Pilot program, part of Operation TrialBlazer — the HHS-wide roadmap announced June 22, 2026 coordinating FDA, NIH, ARPA-H, and the HHS Office of Inspector General to keep early clinical research based in the United States. The pilot pairs qualifying sponsors with vetted Qualified Research Institutions to accelerate first-in-human clinical trial initiation for high-priority biologics: cell and gene therapies, therapeutic vaccines, peptide-based biologics, blood-derived products, and other CBER-scope programs. The comment period for the Request for Information runs through 11:59 p.m. ET on September 22, 2026. FDA plans to select up to 10 investigational programs by end of year. The pilot represents the largest FDA process modernization directly targeting biologics IND timing since the 21st Century Cures Act, and matters for the peptide-industry pipeline because peptide-conjugate cancer vaccines, therapeutic peptide vaccines targeting infectious disease, and peptide-antimicrobial biologics all sit within the CBER regulatory scope and would benefit from the accelerated review timeline.